匹配调整后比较显示，与每周三次皮下注射干扰素β-1a 相比，每两周皮下注射聚乙二醇干扰素β-1a 具有更好的临床结局。
Matching-adjusted comparisons demonstrate better clinical outcomes with SC peginterferon beta-1a every two weeks than with SC interferon beta-1a three times per week.
机构信息
Stony Brook University, Stony Brook, NY, USA.
Biogen, Cambridge, MA, USA.
出版信息
Mult Scler Relat Disord. 2018 May;22:134-138. doi: 10.1016/j.msard.2018.02.021. Epub 2018 Feb 18.
BACKGROUND
Subcutaneous (SC) peginterferon beta-1a and SC interferon beta-1a (IFN beta-1a) have demonstrated efficacy in treating relapsing-remitting multiple sclerosis (RRMS) but have never been compared in direct head-to-head clinical trials, the gold-standard comparison. A well-balanced matching-adjusted comparison of weighted individual patient data on SC peginterferon beta-1a, and aggregate data from published phase 3 clinical trials of SC IFN beta-1a, was conducted to provide additional information on the comparative efficacy of these two agents.
METHODS
Individual patient data from a study of SC peginterferon beta-1a 125 mcg every two weeks (ADVANCE) and pooled summary data from four published studies of SC IFN beta-1a 44 mcg three times per week (OPERA I and II, CARE-MS I and II) with similar populations were utilized. A comparison was conducted by weighting individual peginterferon beta-1a-treated patients, using estimated propensity of enrolling in SC IFN beta-1a treatment to match multiple key aggregate baseline characteristics of SC IFN beta-1a-treated patients. After matching, weighted annualized relapse rate (ARR), 24-week confirmed disability worsening (CDW), and clinical no evidence of disease activity (clinical-NEDA) were calculated and compared for peginterferon beta-1a and SC IFN beta-1a.
RESULTS
After matching, baseline characteristics were well balanced across treatment groups. At 2 years, ARR after matching was 0.256 for patients receiving peginterferon beta-1a (effective n = 376) and 0.335 for those receiving SC IFN beta-1a (n = 1218) (P = 0.0901). The percentage of patients who were relapse free over 2 years was significantly higher with peginterferon beta-1a than with SC IFN beta-1a (75.1% vs. 57.4% [after matching], P < 0.0001). The peginterferon beta-1a treatment group had a significantly lower proportion of patients with 24-week CDW compared with SC IFN beta-1a (after matching 6.5% vs. 13.2%; P = 0.0007). Clinical-NEDA occurred in a significantly higher proportion of patients treated with SC peginterferon beta-1a versus SC IFN beta-1a (74.1% vs. 48.1%; P < 0.0001).
CONCLUSIONS
This matching-adjusted comparison using data from four phase 3 trials with SC IFN beta-1a formulations demonstrated that patients with RRMS treated with SC peginterferon beta-1a 125 mcg every two weeks achieved better clinical outcomes than patients who received SC IFN beta-1a 44 mcg three times per week.
背景
皮下（SC）聚乙二醇干扰素 beta-1a 和 SC 干扰素 beta-1a（IFN beta-1a）在治疗复发缓解型多发性硬化症（RRMS）方面已被证明具有疗效，但从未在直接的头对头临床试验（金标准比较）中进行过比较。通过对 SC 聚乙二醇干扰素 beta-1a 的个体患者数据进行加权匹配调整，并对 SC IFN beta-1a 的已发表的三期临床试验的汇总数据进行综合分析，提供了关于这两种药物比较疗效的额外信息。
方法
利用 SC 聚乙二醇干扰素 beta-1a 125mcg 每两周一次（ADVANCE）研究的个体患者数据和四项已发表的 SC IFN beta-1a 每周三次 44mcg 研究的汇总数据（OPERA I 和 II、CARE-MS I 和 II），对具有相似特征的人群进行了分析。通过使用估计的 SC IFN beta-1a 治疗的倾向性，对 SC 聚乙二醇干扰素 beta-1a 治疗的个体患者进行加权，以匹配 SC IFN beta-1a 治疗患者的多个关键汇总基线特征。匹配后，计算并比较 SC 聚乙二醇干扰素 beta-1a 和 SC IFN beta-1a 的加权年复发率（ARR）、24 周确认残疾恶化（CDW）和临床无疾病活动（临床-NEDA）。
结果
匹配后，各组的基线特征平衡良好。在 2 年时，接受 SC 聚乙二醇干扰素 beta-1a 治疗的患者的 ARR 为 0.256（有效 n=376），接受 SC IFN beta-1a 治疗的患者的 ARR 为 0.335（n=1218）（P=0.0901）。接受 SC 聚乙二醇干扰素 beta-1a 治疗的患者在 2 年内无复发的比例显著高于接受 SC IFN beta-1a 治疗的患者（75.1%比 57.4%[匹配后]，P<0.0001）。接受 SC 聚乙二醇干扰素 beta-1a 治疗的患者 24 周 CDW 的比例显著低于接受 SC IFN beta-1a 治疗的患者（匹配后 6.5%比 13.2%；P=0.0007）。接受 SC 聚乙二醇干扰素 beta-1a 治疗的患者达到临床 NEDA 的比例显著高于接受 SC IFN beta-1a 治疗的患者（74.1%比 48.1%；P<0.0001）。
结论
使用四项 SC IFN beta-1a 制剂的三期临床试验数据进行的这种匹配调整比较表明，接受 SC 聚乙二醇干扰素 beta-1a 125mcg 每两周一次治疗的 RRMS 患者的临床结局优于接受 SC IFN beta-1a 44mcg 每周三次治疗的患者。
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